The United States Food and Drug Administration (FDA) has learned that your firm is marketing Cavi-Lipo in the United States without marketing clearance or approval, in violation of the Federal Food, Drug, and Cosmetic Act (the Act).

Under section 201(h) of the Act, 21 U.S.C. § 321(h), this product is a device because it is intended for use in the diagnosis of disease or other conditions or in the cure, mitigation, treatment, or prevention of disease, or to affect the structure or any function of the body.

The FDA has reviewed your firm’s website and FDA registration and listing information and determined that the Cavi-Lipois adulterated under section 501(f)(1)(B) of the Act, 21 U.S.C. § 351(f)(1)(B), because your firm does not have an approved application for premarket approval (PMA) in effect pursuant to section 515(a) of the Act, 21 U.S.C. § 360e(a), or an approved application for an investigational device exemption (IDE) under section 520(g) of the Act, 21 U.S.C. § 360j(g) for the device as described and marketed. The Cavi-Lipo is also misbranded under section 502(o) the Act, 21 U.S.C. § 352(o), because your firm introduced or delivered for introduction this device into interstate commerce for commercial distribution this device, intended for a use different from the intended use of a legally marketed device in the generic type of device described at 21 CFR 890.5660, Electric Therapeutic Massager without submitting a premarket notification to FDA as required by section 510(k) of the Act, 21 U.S.C. § 360(k), and 21 CFR 807.81(a).

Devices classified under 21 CFR 890.5660, Electric Therapeutic Massager, are exempt from premarket notification unless they exceed the limitations on exemption at 21 CFR 890.9(a). However, there is evidence that the Cavi-Lipo is intended for uses that are different from those of legally marketed devices classified under 21 CFR 890.5660, Electric Therapeutic Massager.Generic devices of this type are intended to use mechanical vibration to manipulate tissue. However, your firm is marketing the Cavi-Lipo for a different intended use, namely for the temporary reduction in the appearance of cellulite. Examples include:

“Cavi-Lipo is one of the most advanced cavitation system and completed ultrasound machanisms [sic].”

“Cavi-Lipo be applied to dissolve cellulites and discharge wastes out of body”

“Cavi-Lipo with stable cavitation, is currently the most evolved system for the treatment of adipose areas and cellulites.”

“Frequency Cavitation system (28KHZ)”

[Cavi-Lipo] “… designed to perform reduction treatment of adipose areas and cellulites, with results that can be compared to liposuction in surgery room”

We reviewed your firm’s promotional labeling and the Cavi-Lipo appears to be an ultrasound diathermy device because it operates beyond 20 KHz to deliver deep heat. However, the Cavi‑Lipo is intended for aesthetic use to dissolve adipose tissue and cellulite and discharge wastes out of the body. Additionally, your firm’s promotional labeling claims the Cavi-Lipo reduces adipose areas and cellulite comparatively to liposuction. Your firm’s device appears to be subject to premarket approval because it is being marketed as an ultrasonic diathermy device for all other uses as described in 21 CFR 890.5300(b). Because there is evidence that the Cavi-Lipo is intended for uses that are different from those of legally marketed devices classified under 21 CFR 890.5660, it exceeds the limitations described in 21CFR 890.9(a) and is not exempt from premarket notification.

For a device requiring premarket approval, the notification required by section 510(k) of the Act, 21 U.S.C. § 360(k), is deemed satisfied when a PMA is pending before the agency. 21 CFR 807.81(b). The kind of information that your firm needs to submit in order to obtain approval or clearance for the device is described on the Internet at http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/HowtoMarketYourDevice/default.htm. The FDA will evaluate the information that your firm submits and decide whether the product may be legally marketed.

Our office requests that SkinRex Co., Ltd. immediately cease activities that result in the misbranding or adulteration of the Cavi-Lipo, such as the commercial distribution of the device for the uses discussed above.

Given the serious nature of the violations of the Act, Cavi-Lipo is subject to refusal of admission under section 801(a) of the Act, 21 U.S.C. § 381(a), in that they appear to be adulterated. As a result, FDA is taking steps to refuse entry of these devices into the United States, known as “detention without physical examination,” until these violations are corrected. In order to remove the devices from detention, your firm should provide a written response to this Warning Letter as described below and correct the violations described in this letter.

Please notify this office in writing within fifteen business days from the date you receive this letter of the specific steps your firm has taken to correct the noted violations, as well as an explanation of how your firm plans to prevent these violations, or similar violations, from occurring again. Include documentation of the corrections and/or corrective actions (which must address systemic problems) your firm has taken. If your firm’s planned corrections and/or corrective actions will occur over time, please include a timetable for implementation of those activities. If corrections and/or corrective actions cannot be completed within fifteen business days, state the reason for the delay and the time within which these activities will be completed. Your firm’s response should be comprehensive and address all violations included in this Warning Letter.

Your firm’s response should be sent to:

Food and Drug Administration

Center for Devices and Radiological Health

Office of Compliance

Field Operations Branch

White Oak Building 66, Rm 2609

10903 New Hampshire Ave.

Silver Spring, MD 20993

Refer to the identification number CMS 414838 when replying. We remind you that only written communication is considered as official. If you have any questions about the contents of this letter, please contact: LaShanda Long, Chief, General Surgery Devices Branch at (301) 796-5770or fax to (301) 847-8137.

Finally, you should know that this letter is not intended to be an all-inclusive list of the violations at your firm. It is your firm’s responsibility to ensure compliance with the applicable laws and regulations administered by FDA.